RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan
treatment and may help patients live more comfortably.
PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with
newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo
chemotherapy compared to how often it happens in healthy volunteers.
- Compare the proportion of hypothyroidism in women with newly diagnosed stage I-IIIB
breast cancer (prior to chemotherapy) vs in cancer-free, age-matched healthy
volunteers.
- Compare the magnitude of change in thyroid function in these patients from baseline to
24 months vs in cancer-free, age-matched healthy volunteers.
Secondary
OUTLINE: This is a pilot, multicenter study.
Patients and age-matched healthy volunteers undergo blood collection at baseline and at 12
and 24 months after enrollment. They also undergo anthropometric measurements and complete
the Fatigue Symptom Inventory at baseline and at 12 and 24 months after enrollment.
PROJECTED ACCRUAL: A total of 270 patients and 280 healthy volunteers will be accrued for
this study.
CASE SELECTION:
- CASE INCLUSION CRITERIA:
- Women between the ages of 25 and 75
- Diagnosed with primary and operable Stage I - IIIB breast cancer
- Scheduled to receive neoadjuvant or adjuvant Adriamycin and Cytoxan (AC) plus a
taxane (taxane may be given with AC or follow AC)
- No chemotherapy prior to baseline sample collection
- No prior history of other cancers (except non-melanoma skin cancer)
- Preoperative radiation therapy is permitted
- No diagnosis of hypothyroidism or hyperthyroidism.
- CASE EXCLUSION CRITERIA:
- Stage IV breast cancer
- Scheduled to receive neoadjuvant hormonal therapy (patients who will receive adjuvant
hormonal therapy may participate)
- Received adjuvant hormonal therapy or chemotherapy prior to sample collection
- On chemotherapeutic regimen other than Adriamycin and Cytoxan plus a taxane.
- Patients receiving monoclonal antibodies or other biologic therapy may not
participate
- Patients scheduled to receive Herceptin may not participate
- Diagnosed with hyperthyroidism or hypothyroidism. (Women being treated for
hypothyroidism are not eligible)
- Women with a baseline TSH of 10 or higher will not continue on study
- Women who are pregnant or lactating are not eligible. (Women of childbearing
potential who are planning to become pregnant within the next 24 months should not
enroll in this study)
CONTROL SELECTION:
- CONTROL INCLUSION CRITERIA:
- Cannot be a blood relative of the case. They can be friends, neighbors, women from
social activities, local business, doctors' offices, etc.
- Must live near or in the town of the case
- Women between the ages of 20 and 80 (age-matched to cases +/- 5 years)
- No prior history of cancer (except non-melanoma skin cancer)
- Women ages 40 and older should have had a mammogram within 2 years of study entry,
showing no evidence of breast cancer.
- The friend control may bring their mammogram report or send a release and have
records faxed to the enrolling center.
- Women under the age of 40 should have had a clinical breast examination within 2
years of study entry, showing no need for diagnostic mammography. If a mammogram was
required, it should show no evidence of breast cancer.
- The friend control may bring their mammogram / breast exam report or send a release
and have records faxed to the enrolling center.
CCOP - Western Regional, Arizona, Phoenix, Arizona 85006-2726, United States
North Colorado Medical Center, Greeley, Colorado 80631-5199, United States
McKee Medical Center, Loveland, Colorado 80538, United States
Cancer Centers of Central Florida, PA, Leesburg, Florida 34788, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida 33612-9497, United States
Northeast Georgia Cancer Care, LLC - Medical Oncology, Athens, Georgia 30607, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia 30912-4000, United States
Medical College of Georgia Cancer Center, Augusta, Georgia 30912-3500, United States
Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois 62002, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois 62864, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana 71130-3932, United States
CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan 48073, United States
William Beaumont Hospital - Troy Campus, Troy, Michigan 48085, United States
MeritCare Bemidji, Bemidji, Minnesota 56601, United States
Saint Francis Medical Center, Cape Girardeau, Missouri 63703, United States
Southeast Cancer Center, Cape Girardeau, Missouri 63701, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri 63141, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65804, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri 65807, United States
St. John's Regional Health Center, Springfield, Missouri 65804-2263, United States
CCOP - St. Louis-Cape Girardeau, St. Louis, Missouri 63141, United States
Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States
MBCCOP - Our Lady of Mercy Comprehensive Cancer Center, Bronx, New York 10466, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York 10466, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States
Rutherford Internal Medicine Associates, PA, Forest City, North Carolina 28043, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States
Southeastern Medical Oncology Center - Goldsboro, Goldsboro, North Carolina 27534, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina 27403-1198, United States
Pardee Memorial Hospital, Hendersonville, North Carolina 28791, United States
Iredell Memorial Hospital, Statesville, North Carolina 28687-1828, United States
Southeastern Medical Oncology Center - Wilson, Wilson, North Carolina 27893, United States
Forsyth Regional Cancer Center at Forsyth Medical Center, Winston-Salem, North Carolina 27103, United States
CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States
Roger Maris Cancer Center at MeritCare Hospital, Fargo, North Dakota 58122, United States
AnMed Cancer Center, Anderson, South Carolina 29621, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States
CCOP - Scott and White Hospital, Temple, Texas 76508, United States
Scott and White Cancer Institute, Temple, Texas 76508, United States
